BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE SPIRAL FLUTED DRILL BIT

    MDR report key: 7276557 · Received February 16, 2018

    Report

    Report Number
    1221934-2018-50187
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT DEVICE IS NOT BEING RETURNED AS IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT: DHR REVIEW, PART NUMBER: 211042, SUPPLIER LOT NUMBER: 0909002, RELEASE TO WAREHOUSE DATE: 10-15-09, SUPPLIER: (B)(4), MANUFACTURING SITE: NA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP DURING A SHOULDER ARTHROSCOPY THAT THE CUSTOMER'S LUPINE DRILL BIT WAS DULL. THE DOCTOR COMPLETED THE PROCEDURE WITH THE DEVICE, BUT REQUESTED IT BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121074 LUPINE SPIRAL FLUTED DRILL BIT SURGICAL HAND DRILL HTW DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1